Clinical Research Program Coordinator

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Position: Clinical Research Program Coordinator

Department: Oncology

Schedule: Full Time

POSITION SUMMARY:

The Clinical Research Laboratory at Boston University Medical Center is looking for a highly motivated Clinical Research Program Coordinator to conduct clinical and translational research.

The responsibilities will be split evenly across the Hematology and Medical Oncology section at Boston Medical Center (BMC) and the Clinical Research program at Boston University Graduate Medical Sciences (GMS).

Under the supervision of the Principal Investigators and with some leadership by the Clinical Research Nurse Coordinator and Administrative Director for assigned research studies, the Clinical Research Coordinator (CRC) will perform research activities using approved techniques.

The CRC procures, processes and ships research specimens and conducts patient recruitment, administers questionnaires, abstracts medical records, maintains patient databases, enters data into sponsor-specific electronic data capture forms, performs administrative tasks, assists in grant preparation, and participates with the research team in preparation of data and other reports.

Will also assist with audits and quality assurance reviews; and prepares and attends site visits.

Prepares and presents data reports and oversees work of research assistants.

Assists with the preparation of IRB applications and document maintenance and collects and processes biological specimens for appropriate studies when needed (Ex: blood, saliva, NP swabs).

Responsibilities at the BMC Clinical Research Laboratory include maintenance of IRBs, screening participants, data collection, literature reviews, and grant and manuscript preparation.

Responsibilities for the GMS Clinical Research program include student advising, admissions and program promotion and outreach.

This position is funded for one year initially, with the possibility for longer-term employment.

ESSENTIAL RESPONSIBILITIES / DUTIES:

Evaluating and tracking the eligibility of all patients seen in the clinic. Recruits subjects to participate in the study by using approved methodologies, such as, reaching to healthcare providers for referrals, visiting clinics, using approved advertisements.

Conducts the enrollment of study participants, including explaining research procedures, and obtaining informed consent of subject and registering patients to cohort studies and other protocols. 

Schedules appointments of study participants; conducts reminder phone calls and/or sends mail-outs.

Performs biospecimen collection for study purposes, including: blood (phlebotomy), saliva (cheek swabs), and placental tissue.

Process biospecimens in the lab including blood, urine, breastmilk, and placental samples from COVID-19 positive women and infants.

Performs office-related duties such as answering phones, picking up and delivering mail, storing and distributing office supplies, handling faxes, scanning, filing, photocopying, collating materials, maintaining the update of policy manuals, etc.

Participates in staff meetings/initiatives including appropriate quality improvement and education activities, or if unable to attend non-mandatory activities, accepts responsibility to review meeting minutes and becomes knowledgeable of issues discussed.

Reviews and abstracts the medical records for patients, including review of all records for inclusion/exclusion criteria.

Accessing patient demographic and clinical information from the clinical systems.

Entering information into the appropriate EMR and eCRF systems and departmental systems in an accurate manner.

Reviewing data for quality and completeness for each enrollee for completion and quality (QA).

Answers queries; performs data collection entry into database; maintains clear, concise, accurate and legible records.

Assists with the coordination of the collection, processing, organization, and storage of biological specimens in the systems

May assist in the preparation for IRB and regulatory submissions and maintenance of regulatory files

Maintaining on-going communications with research managers and PIs for data collection needs.

May train or orient new research assistants and other staff.

Must adhere to all of BMC’s RESPECT behavioral standards.

(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job.

The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).

JOB REQUIREMENTS

EDUCATION:

CRC II: Experienced Level Position

Master’s Degree OR

2-5 years of experience

Special Intermittent Project Responsibilities (2-5 per year)

CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED :

None.

EXPERIENCE:

Included within Education above

Experience in a clinical research setting highly desirable.

Experience working with women with substance use disorders also strongly preferred.

Experience with phlebotomy and lab research is desired but can also be learned early on in the position and is not required at the time of hire.

KNOWLEDGE AND SKILLS:

Excellent organization and communications skills required.

Strong interpersonal skills; ability to effectively interact with all levels of staff and externals contacts.

Cultural sensitivity and comfort with a wide range of social, racial and ethnic populations

Language skills a plus

Must be detail oriented and have the ability to follow-through.

Ability to effectively manage time and prioritize workload.

Must practice discretion and adhere to hospital confidentiality guidelines at all times.

Must have high degree of computer literacy, including the use of Microsoft Office Suite

Ability to work independently

Analytical skill and ability to resolve technical problems and interpret acceptability of data results.

Phlebotomy skills a plus

Essential Responsibilities for the Clinical Research Laboratory at BMC:

Observe and assist with data collection

Attend weekly project meetings of study investigators and research staff

Maintain participant confidentiality

Assist with study progress reports, posters, abstracts

Administer Study assessments

Submit and amend IRB protocols

Maintain RedCAP database

Data analysis, experience with R, SAS, Stata and qualitative coding

Conduct literature reviews

Assist in preparation of manuscripts, presentations and grants as requested

Essential Responsibilities for the Clinical Research Program at GMS:

Assist with student admissions

Advise incoming and current students

Assist with program promotion and outreach

Meet regularly with the Director and Assistant Director of the Clinical Research Program

Qualifications

Bachelor’s Degree required, Master’s Degree preferred with a major in medical sciences or clinical research preferred.

Good organizational and interpersonal skills and a working knowledge of data management, word processing, and graphic software is preferred.

Must have excellent communication skills (including spoken and written English) and be able to work with a wide variety of faculty and staff.

Must have attention to detail and be thorough in completing work tasks.

The position is expected to work full time (40 hours/week) for one year with option to extend position beyond this term.

Ability to work in a team and with some independence.

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